Recordkeeping CGMP for Medical Gases, Containers, and Closures

Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Medical Gases and Active Pharmaceutical Ingredients)

OMB: 0910-0139

IC ID: 215453

Documents and Forms
Document Name
Document Type
Other-Agency Guidance
Other-Agency Guidance
Information Collection (IC) Details

View Information Collection (IC)

Recordkeeping CGMP for Medical Gases, Containers, and Closures CDER
 
No Modified
 
Mandatory
 
21 CFR 225; 226 21 CFR 600 through 680 21 CFR 1271 21 CFR 210; 211  (To search for a specific CFR, visit the Code of Federal Regulations.)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance GFI for Medical Gases CDER draft.pdf Yes No Printable Only

Health Public Health Monitoring

 

2,284 0
   
Private Sector Businesses or other for-profits
 
   100 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 639,520 0 0 -1,574 0 641,094
Annual IC Time Burden (Hours) 396,502 0 0 -486 0 396,988
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
No associated records found
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

© 2024 OMB.report | Privacy Policy